Committee backs draft rulemaking for accessible prescription drug labels; members debate signature requirement and accommodations

The Committee voted on June 11, 2025, to initiate rulemaking for a proposed regulation (draft 17.07.51) requiring pharmacies to adopt policies and procedures to provide accessible prescription drug labels upon request.

The draft regulation would require pharmacies to maintain a written policy that includes: (1) a documented method to determine a patient’s accessibility needs; (2) a list of accessibility options available at that pharmacy; (3) any deviations from standard labeling required to deliver an accessible format; (4) a description of training provided to pharmacy personnel on the policy; and (5) recordkeeping requirements. The draft also references existing statutory language that requires information be made “appropriate to the disability and language of the person” through large print, braille, audio or translated directions.

Members and public commenters debated practical and legal questions. Some members asked whether spoken or audio labels could satisfy the statute’s written‑label requirement; board counsel advised that the statute and its implementing text refer specifically to a written label that is affixed to the container or to a supplemental written document. Counsel said pharmacies may offer additional formats beyond the statutorily required written document, but a written version remains central to the statutory scheme.

Commenters raised timeliness and patient‑safety concerns: pharmacies must balance accessibility accommodations with clinical timeliness (for example, not delaying an antibiotic while producing a special label). Members said a pharmacy policy could permit an immediate, temporary dispensing with an accessible‑format plan for subsequent refills or follow up. Public commenters asked staff to remove subsection (b) in the draft requiring pharmacy personnel to read and sign the policy; proponents of keeping the subsection noted signed attestations can document staff training and assist the pharmacist in charge when investigating a complaint. Committee members did not reach a single consensus on removing the signature requirement and the language will be included in rulemaking as presented for additional public input and board consideration.

The committee approved a motion to initiate the rulemaking file and authorized the Executive Officer to refine non‑substantive language consistent with the committee’s discussion and to present the proposed rulemaking to the full Board.